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These included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the SEREVENTO DISKUS" frontal cranial bones. No significant effects occurred at an oral dose of 0.6 mgtkg(approximately 20 ffmes the maximum recommended daily inhalation dose in adults based on comparison of the AUCs). (salmeterol xinafoate inhalation powder) New Zealand White rabbits were less sensitive since only delayed ossification of the frontal bones was seen at an oral dose of 10 mg/kg (approximately 1700 ffmes the maximum recom(mended daily inhalation dose in adults on a Mg/M2 basis). Extensive use of other beta-agonists has provided no evidence that these class For Oral Inhalation Only effects in animals are relevant to their use in humans. There are no adequate and well controlled studies with SEREVENT DISKUS in pregnant women. SEREVENT The following is a bdef summary only; see full prescdbing informaton fbr complete product information. DISKUS should be used during pregnancy only if the potential benefit jusfffies the potential risk to the fetus. Use in Labor and Delivery: There are no well coDntroiled human studies that have invesffated effects of salmeterol on preterm labor or labor at term. Because of CONTRAINDICATIONS: SEREVENT DISKUS is contraindicated in patients with a history of hypersensifivity to salmeterol or any of its components. the potential for beta-agonist interference with uterine contractility, use of SEREVENT DISKUS for relief of bronchospasm during labor should be restricted to those paffents in whom the benefits clearly outweigh the risks. WARNINGS: Nursing Mothers: Plasma levels of salmeterol after inhaled therapeutic doses are very low. In rats, salmeterol xinafoate is excreted in the milk. However, since there IMPORTANT INFORMATION: SEREVENT DISKUS SHOULD NOT BE INMATED IN PATIENTS WITH SIGNIRCANTLYWORSENING OR ACUTELY DETERIORATING are no data from oontrolled trials on the use of SEREVENT by nursing mothers, a decision should be made whether to discDntinue nursing or to disconffnue the ASTHMA, WHICH MAY BE A UFE-THREATENING CONDITION. Serious acute respiratory events, lnduding feblities, have been reported, both In the drug, taking into account the importance of the drug to the mother. Cauffon should be exercised when salmeterol xinafoate is administered to a nursing woman. Unfted States and woddwide, when SEREVENT has been lnftlated In this situation. Pediatric Use: The safety and efficacy of salmeterol inhalation powder has been evaluated in over 2500 patients aged 4 to 11 years with asthma, 346 of whom were Afthough It Is not possible from these reports to determine whether SEREVENT contributed to these adverse events or simply failed to relieve the administered salmeterol inhalaffon powder for 1 year. Based on available data, no adjustment of salmeterol dosage in pediatric paffents is warranted for either asthma detedwating asthma, the use of SEREVENT DISKUS In this setting Is Inappropriate. or EIB (see DOSAGE AND ADMINISTRATION secffon of full prescribing information). SEREVENT DISKUS SHOULD NOT BE USED MTREAT ACUTE SYMPMMS. h Is crucial to Inform pedents of thls and prescribe an Inhaled, short-acting In two randomized, double-blind, oontrolled clinical traias of 12 weeks' duration, salmeterol 50-mcg powder was administered to 211 pediatric asthma patients who be"onist for this purpose as well as warn them that Increasing Inhaled bet"onist use Is a signal of deteriorefing asthma. did and who did not reoeive concurrent inhaled corticosteroids. The efficacy of salmeterol inhalabon powder was demonstrated over the 12-week treatment period SEREVENT DISKUS IS NOT A SUBSTITUTE FOR INHALED OR ORAL CORTICOSTEROIDS. Corticosterolds should not be stopped or reduced when with respect to peak expiratory flow and FEVI. Salmeterol inhalation powder was effecffve in demographic subgroups (gender and age) of the population. Salmeterol SEREVENT DISKUS Is lnhisted. was effecfive when coadministered with other inhaled asthma medicaffons, such as short-acting bronchodilators and inhaled cortioosteroids. Salmeterol inhalation (See PRECAUTIONS: Information for PaUents and the PATIENrs INSTRUCTIONS FOR USE leeflet.) powder was well tolerated in the pediatrc population, and there were no safety issues identified specific to the administraffon of salmeterol inhalation powder to 1. Do Not Introduce SEREVENT DISKUS as a Treatment for Acutely Deteriorating Asthma: SEREVENT DISKUS is intended for the maintenance treatment of asthma pediatric paffents. (see INDICATIONS AND USAGE secton of full prescribing information) and should not be introduced in acutely detedorating asthma, which is a potentially In two randomized studies in children 4 to 11 years old with asthma and EIB, a single 50-mog dose of salmeterol inhalation powder prevented EIB when dosed life-threatening oondition. There are no data demonstrating that SEREVENT DISKUS provides greater efficacy than or additional efficacy to inhaled, short-acting 30 minutes prior to exercise, with protection lasting up to 11.5 hours in repeat testing following this single dose in many patients. beta2-agonists in pabents with worsening asthma. Sedous acute respiratory events, induding fatalities, have been reported, both in the United States and woddwide, Geriatric Use: Of the total number of patients who received salmeterol inhalation powder in adolescent and adult chronic dosing clinical trials, 209 were 65 years of in pabents receiving SEREVENT In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low age and older. No apparent differences in the efficacy and safety of SEREVENT inhalation powder were observed when geriatric patients were compared with pulmonary function, intubation, mechanical ventlabon, frequent hospitalizations, or previous life-threatening acute asthma exacerbabons) and/or in some patients in younger paffents in clinical trials. As wfith other beta2-agonists, however, special cauffon should be observed when using SEREVENT inhalaffon powder in geriatric whom asthma has been acutely detedorating (e.g., unresponsive to usual medications; increasing need for inhaled, short-acbng beta2-agonists; increasing need for paffents who have concomitant cardiovascular disease that could be adversely affected by this class of drug. Based on available data, no adjustment of salmeterol systemic corficosteroids; significant increase in symptoms; recent emergency room visits; sudden or progressive detedorabon in pulmonary funcfion). However, they dosage in geriatric paffents is warranted. have occurred in a few patents whh less severe asthma as well. It was not possible fmm these reports to determine whether SEREVENT oDntfibuted to these events or simply failed to relieve the detedorafing asthma. ADVERSE REACTIONS: Adverse reacfions to salmeterol are similar in nature to reactions to other selecfv beta2-adrenoooptor agonists, i.e., tachycardia; palpitaffons; 2. Do Not Use SEREVENT DISKUS to Treat Acute SympjoM& An inhaled, short-acbng b8ta2-agonist, not SEREVENT DISKUS, should be used to relieve acute immediate hypersensibvity reacffons, including urticaria, angioedema, rash, bronchospasm (see WARNINGS); headache; tremor; nervousness; and paradoxical bron- asthma symptoms. When prescdbing SEREVENT DISKUS, the physician must also provide the patient with an inhaled, short-acbng beta2-agonist (e.g., albuterol) for chospasm (see WARNINGS). treatment of symptoms that occur acutely, despite regular twice-daity (morning and evening) use of SEREVENT DISKUS. Two mulifcenter, 12-week, coDntrolled studies have evaluated twice-daily doses of SEREVENT inhalation powder in paffents 12 years of age and older with asthma. When beginning treatment with SEREVENT DISKUS, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a The following table reports the incidence of adverse events in these two studies. day) should be instructed to disconfinue the regular use of these drugs and use them only for symptomabc relief of acute asthma symptoms (see PRECAUTIONS: lnformaton for Patients). Adverse Exiperlence Incidence in Two L,arge 12-Week Adolescent and Adutt Clinical Trials 3. Watch for Increasing Use of Inhaled, Short-Acbng Beta,-Aggnists, Which Is a Marker oi Detedorafing Asthma: Asthma may detedorate acutely over a pedod of hours or chronically over several days or kNer. If the pafienfs inhaled, short-acting beta2-agonist becomes less effecbve or the patent needs more inhalafions
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